0 Evaluaciones

ID

12127

Descripción

Total Ankle Replacement Versus Arthrodesis Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02128555

Link

https://clinicaltrials.gov/show/NCT02128555

Palabras clave

  1. 28/9/15 28/9/15 - Julian Varghese
Subido en

28 de septiembre de 2015

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Osteoarthritis NCT02128555

    Eligibility Osteoarthritis NCT02128555

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of end-stage ankle osteoarthritis
    Descripción

    end-stage ankle osteoarthritis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0409931
    UMLS CUI [1,2]
    C0205088
    aged 50-85 years inclusive
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    the surgeon believes the patient is suitable for both tar and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
    Descripción

    Eligibility Determination; Total ankle replacement | Eligibility Determination; Arthrodesi

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013893
    UMLS CUI [1,2]
    C0188664
    UMLS CUI [2,1]
    C0013893
    UMLS CUI [2,2]
    C0003881
    the patient is able to read and understand the patient information sheet (pis) and trial procedures
    Descripción

    able to read and understand information sheet

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    the patient is willing and able to provide written informed consent
    Descripción

    patient is willing and able to provide written informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
    Descripción

    surgery planned within 1 year

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0003881
    more than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
    Descripción

    4 lower limb joints fused

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0003881
    • unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)
    Descripción

    unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0522473
    UMLS CUI [1,2]
    C0024485
    UMLS CUI [2,1]
    C0522473
    UMLS CUI [2,2]
    C0040405
    history of local bone or joint infection
    Descripción

    history of local bone or joint infection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0851989
    any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety
    Descripción

    patient safety comorbidity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0150755
    UMLS CUI [1,2]
    C0009488
    participant in another clinical trial that would materially impact on their participation in this study
    Descripción

    participation status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Osteoarthritis NCT02128555

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    end-stage ankle osteoarthritis
    Item
    diagnosis of end-stage ankle osteoarthritis
    boolean
    C0409931 (UMLS CUI [1,1])
    C0205088 (UMLS CUI [1,2])
    Age
    Item
    aged 50-85 years inclusive
    boolean
    C0001779 (UMLS CUI [1])
    Eligibility Determination; Total ankle replacement | Eligibility Determination; Arthrodesi
    Item
    the surgeon believes the patient is suitable for both tar and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
    boolean
    C0013893 (UMLS CUI [1,1])
    C0188664 (UMLS CUI [1,2])
    C0013893 (UMLS CUI [2,1])
    C0003881 (UMLS CUI [2,2])
    able to read and understand information sheet
    Item
    the patient is able to read and understand the patient information sheet (pis) and trial procedures
    boolean
    C0021430 (UMLS CUI [1])
    patient is willing and able to provide written informed consent
    Item
    the patient is willing and able to provide written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    surgery planned within 1 year
    Item
    previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
    boolean
    C0003881 (UMLS CUI [1])
    4 lower limb joints fused
    Item
    more than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
    boolean
    C0003881 (UMLS CUI [1])
    unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)
    Item
    • unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan)
    boolean
    C0522473 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    C0522473 (UMLS CUI [2,1])
    C0040405 (UMLS CUI [2,2])
    history of local bone or joint infection
    Item
    history of local bone or joint infection
    boolean
    C0851989 (UMLS CUI [1])
    patient safety comorbidity
    Item
    any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety
    boolean
    C0150755 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    participation status
    Item
    participant in another clinical trial that would materially impact on their participation in this study
    boolean
    C2348568 (UMLS CUI [1])

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